48. A drug manufacturer submits a New Drug Application (NDA) to a regulatory agency. What medicinal epidemiological evidence is critically required to support this application?
A.
Anecdotal reports from patients.
B.
Robust evidence of efficacy and safety from Phase III clinical trials.
✓
C.
Only pre-clinical animal studies.
D.
Opinions from key opinion leaders.
📖 Additional Information
Anecdotal reports from patients.
Robust evidence of efficacy and safety from Phase III clinical trials.
